Urinary incontinence (“UI”) occurs in both men and women. Various types of incontinence are caused by different conditions and call for different treatments. For example, stress urinary incontinence (“SUI”) is known to be caused by at least two conditions, intrinsic sphincter deficiency (“ISD”) and hypermobility. Moreover, UI is often caused or exacerbated by pelvic floor disorders. According to some studies, about 1 out of 11 women need surgery for a pelvic floor disorder during her lifetime. The pelvic floor generally includes muscles, ligaments, and tissues that collectively act to support anatomical structures of the pelvic region, including the uterus, the rectum, the bladder, and the vagina. Pelvic floor disorders include vaginal prolapse, vaginal hernia, cystocele, rectocele, and enterocele. Such disorders are characterized in that the muscles, ligaments and/or tissues are damaged, stretched, or otherwise weakened, which causes the pelvic anatomical structures to fall or shift and protrude into each other or other anatomical structures. Often, treatments of stress incontinence are made without treating the pelvic floor disorders at all, potentially leading to an early recurrence of the pelvic floor disorder.
One way to treat UI, both in men and women, is to place a surgical sling or suture in the periurethral tissue such as under the bladder, bladder neck or the urethra to provide a support platform. Placement of the sling helps to address UI by limiting mobility of the bladder neck or limits the endopelvis fascia drop while providing compression under event stress to improve urinary function. The sling may also be configured to address pelvic floor disorders by being positioned under a prolapsed organ in the pelvic region.
Current support slings are typically affixed using a bone anchoring method or a suture applied to the buttock, groin, or other area in the patient's pelvic region. Alternatively, an operator uses an anchorless approach to stabilize the urethra with a sling by placing the sling in the periurethral tissue and relying on tissue compression and eventual tissue in-growth to secure the sling in position.
Various transvaginal, suprapubic, and trans-obturator approaches have been used for sling placement. In the case of trans-obturator approaches, current approaches use a needle delivery device having a fixed radius of curvature. Often such technique is performed in an “inside-out” fashion that involves inserting a delivery device and support sling through a vaginal incision in a patient, then tunneling the sling through the patient's obturator foramen and then through a groin incision. The tissue in the posterior region of the obturator foramen includes sensitive vascular and nerve tissues which may be punctured by the device as it tunnels through the obturator foramen. Alternative transobturator approaches include an “outside-in” approach in which the needle is tunneled from a groin incision to a vaginal incision and associated with the implant. The implant is then drawn back through the passage and out the groin incision. It would be desirable to provide a sling delivery device with a geometry that allows the shaft of the delivery device to track closely around a bodily structure, such as the ischiopubic ramus, during the advance of the delivery device through the tissue to allow the device to by-pass sensitive posterior obturator foramen tissues. Accordingly, devices, systems, and methods are desirable that can track a curved path with varying radius for positioning a mid-urethral sling to treat urinary incontinence, while minimizing the risk of injury to the patient.